Adefovir Dipivoxil is a known nucleotide reverse transcriptase inhibitor used in clinic for the treatment of retrovirus infections, in particular HIV and HBV infections (U.S. Pat. No. 5,663,159).
WO 99/04774 and U.S. Pat. No. 6,451,340 disclose Adefovir crystalline forms, and particularly the crystalline form 1 (anhydrous) and the crystalline form 2 (dihydrate KF=6.7%).
The two crystalline forms were prepared and characterized. The analysis of form 1 is reported in FIGS. 1-3 whereas the analysis of form 2 is reported in FIGS. 4-6.
WO 00/35460 discloses pharmaceutical formulations comprising anhydrous and dihydrate Adefovir Dipivoxil and an alkali excipient.